Study to collect long-term clinical data for the recharge free Axonics SNM System (INS Model 4101)
- Conditions
- rinary urge incontinence (UUI) with or without urinary frequency (UF) and/or chronic fecal incontinence (FI)Not Applicable
- Registration Number
- ISRCTN19352412
- Lead Sponsor
- Axonics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 80
1. Aged 18 years or older
2. Provides written informed consent
3. Primary indication of UUI (with or without UF) or chronic FI who failed or could not tolerate more conservative treatments and implanted with the Axonics F15 SNM System and who have reached 1-year or greater, post-implant
4. Completion of a baseline pre-PNE 3-day bladder diary for UUI or a minimum of 7-day pre-PNE bowel diary for FI
5. English speaking
1. Any significant medical condition that is likely to interfere with trial procedures, device operation, or likely to confound evaluation of trial endpoints (i.e., exclusion of neurological conditions such as multiple sclerosis)
2. Any psychiatric or personality disorder that is likely to interfere with trial procedures at the discretion of the participating physician; this may include poor understanding or compliance with trial requirements
3. A female who is breastfeeding
4. A female with a positive urine pregnancy test
5. Intradetrusor chemodenervation with OnabotulinumtoxinA (Botox) injections within 6 months prior to study follow-up visit
6. Prior history of pelvic or rectal cancer
7. Prior history of pelvic radiation
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison from baseline to follow-up for the following:<br>1. =50% reduction in UUI episodes per day on a 3-day bladder diary OR<br>2. =50% reduction in FI episodes on a minimum of 5-day bowel diary<br>
- Secondary Outcome Measures
Name Time Method Comparison from baseline to follow-up for the following:<br>1. Complete urinary or fecal continence measured using a bladder or bowel diary<br>2. Device parameters (programming settings, impedance values) measured using the Clinician Programmer (CP), a tablet computer used by the clinician (or sponsor representative) to wirelessly communicate with the neurostimulator to check the device status and/or program the device<br>3. Procedure and/or device-related adverse events as reported in source documents by the physician and/or research staff<br>4. Serious adverse events (SAEs) as reported in source documents by the physician and/or research staff<br>5. Patient satisfaction measured using a Patient Satisfaction Questionnaire